Clinical Supply Chain Associate

Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.
 
Job Summary
The Clinical Supply Chain Associate will support clinical drug supply activities related to planning, label development, packaging and labeling documentation, and distribution documentation for one or more clinical programs. Supports Clinical Supply Team to ensure supply plans are accurate and enable continuous supply to patients around the globe while reducing risk and minimizing waste. Has a working knowledge of clinical supply best practices, IRT systems, as well as experience working within a cGMP environment. 
Requirements
Education & Experience

• BS degree in life science or technical discipline. A degree in Supply Chain Management or certification is preferred.
• At least 3+ years experience in Clinical Supply Chain preferably within the biotech, pharmaceutical, CRO, industry.
• Familiarity with clinical trials and supply chain processes is required.
• Basic understanding of global regulations for investigational medicinal products is a plus.
• Experience or coursework related to logistics, inventory management, or pharmaceutical materials is desirable.

Knowledge, Skills, and Competencies

• Strong management and organizational skills and detail orientation with an ability to prioritize, enable, and accelerate multiple programs and projects while simultaneously delivering against the activities of daily operations.
• Ability to thrive in a multidisciplinary team environment is essential for success, with a strong ability to build relationships.
• Proven agility and success in a dynamic company / business environment where change is frequent and rapid understanding and alignment is paramount.
• Computer skills including Microsoft Office Suite products and working knowledge of various operational software systems including IRT software.
• Thorough understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials.
• Excellent project management and communication skills, with particular emphasis on negotiating and problem solving.

Responsibilities

• Assist the Clinical Supply Chain Team  in supporting Clinical Study Teams (CST) and providing service to internal stakeholders (e.g., Clinical Operations, Regulatory, Quality, CMC).
• Review and approve CMOs clinical packaging, labeling and distribution documentation.
• Support the creation and maintenance of supply and inventory plans for clinical trial materials.
• Monitor production schedules and inventory under supervision, report discrepancies or issues to the Team.
• Assist in managing GMP inventory, preparing inventory reports, and tracking drug accountability.
• Support relationships and daily activities with label & pack CMOs and distribution vendors as directed.
• Help investigate exceptions and support implementation of corrective actions under guidance.
• Assist in ensuring label text and proofs meet applicable rules, regulations, and study protocols.
• Coordinate review and approval of labels with stakeholders and CMOs as assigned.
• Support IRT user acceptance testing and ongoing supply activities in the system.
• Help coordinate and track shipments to CMOs, depots, and vendors; assist with import license tracking.
• Contribute to supply strategies to maximize efficiency and minimize waste, under supervision.
• Participate in cross-functional projects and process improvements related to drug supply as assigned.
• Assist in the creation of Standard Operating Procedures.
• Support change controls for Clinical Supply Chain as directed.
• All other duties as assigned.

Benefits
Liquidia offers a competitive compensation package as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, and more!
 
Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.
 
Recruiting Agencies, Please Note:
Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.